FDA
FDA approves Datroway after survival benefit in first-line metastatic triple-negative breast cancer
Triple-negative breast cancer remains one of the most difficult breast cancer subtypes to treat, and options are especially limited for patients who cannot receive immunotherapy. On May 22, 2026, FDA approved Datroway (datopotamab deruxtecan-dlnk) for adults with unresectable or metastatic triple-negative breast cancer who aren't candidates for PD-1/PD-L1 inhibitor therapy, adding a new first-line option beyond chemotherapy alone.
The approval was based data from TROPION-Breast02, a phase 3 trial comparing Datroway with investigator’s choice of chemotherapy. Datroway improved median overall survival by 5.0 months, with overall survival of 23.7 months versus 18.7 months for chemotherapy (hazard ratio, 0.79; P=.0290). It also improved progression-free survival, with a median of 10.8 months versus 5.6 months with chemotherapy (hazard ratio, 0.57; P<.0001), and doubled the objective response rate, 64% versus 30%.
This approval is clinically important because many patients with metastatic triple-negative breast cancer aren't eligible for PD-1/PD-L1 inhibitor therapy, leaving chemotherapy as the only first-line choice. Datroway is the first TROP2-directed antibody-drug conjugate approved for this setting and offers a targeted alternative for a population with a high unmet need.
“For seven out of 10 patients with metastatic triple negative breast cancer who are not candidates for immunotherapy, chemotherapy has remained the only treatment option,” said Arlene Brothers, Executive Director, Triple Negative Breast Cancer Foundation. “Approval of Datroway means that for the first time, these patients will have a new standard of care beyond traditional chemotherapy at the outset of their treatment.”
Safety findings were consistent with the known profile of the drug. Common adverse reactions included stomatitis, nausea, fatigue, alopecia, constipation, vomiting, decreased appetite, and ocular toxicities such as dry eye and keratitis. Serious adverse reactions occurred in 17% of patients, and one fatality was attributed to interstitial lung disease (ILD)/pneumonitis. Clinicians should monitor for ILD/pneumonitis, stomatitis, and ocular adverse effects during treatment.
“Datopotamab deruxtecan is the first and only medicine to significantly prolong overall survival in the first-line setting compared to chemotherapy in patients with metastatic triple negative breast cancer who are not candidates for immunotherapy,” said Tiffany A. Traina, MD, FASCO, Section Head of the Triple Negative Breast Cancer Clinical Research Program at Memorial Sloan Kettering Cancer Center and investigator for the TROPION-Breast02 trial. “This approval will bring a much-needed treatment option for these patients.”
Source: Daiichi Sankyo and AstraZeneca. (2026, May 22). Press release. Datroway approved in the U.S. as first TROP2 directed antibody drug conjugate for first-line treatment of patients with metastatic triple negative breast cancer who are not PD-1/PD-L1 inhibitor candidates